Beckman Coulter, Inc. is recalling 231 units of the DxI 9000 Access Immunoassay Analyzer (Catalog Number C11137) running software version 1.20. A software error causes the analyzer to generate error codes that prevent medical tests from being performed, leading to significant delays in patient results. This issue may require field service from the manufacturer to resolve.
The software failure prevents the device from running diagnostic assays, which can cause clinical laboratories to experience delays in delivering critical test results. These delays can interfere with timely medical diagnosis and treatment decisions.
Recall affects analyzers running software version 1.20.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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